Device for biopsy and treatment of breast tumors

ABSTRACT

A device for diagnosis and treatment of tumors and lesions within the body. A cannula adapted to apply suction through the lumen of the catheter to the tumor or lesion is described. The lumen has a self sealing valve through which a cryoprobe is inserted while the suction is being applied. The cryoprobe is then inserted into the lesion, and operated to ablate the lesion.

[0001] This application is a continuation of U.S. application Ser. No.09/598,124, filed Jun. 21, 2000, now U.S. Pat. No. 6,494,844.

FIELD OF THE INVENTIONS

[0002] The devices and method described below relate to the diagnosisand treatment of breast lesions, and more generally, to the diagnosisand treatment of tumors and lesions throughout the body.

BACKGROUND OF THE INVENTIONS

[0003] Biopsy is an important procedure used for the diagnosis ofpatients with cancerous tumors, pre-malignant conditions, and otherdiseases and disorders. Typically, in the case of cancer, when thephysician establishes by means of procedures such as palpation,mammography or x-ray, or ultrasound imaging that suspiciouscircumstances exist, a biopsy is performed. The biopsy will helpdetermine whether the cells are cancerous, the type of cancer, and whattreatment should be used to treat the cancer. Biopsy may be done by anopen or percutaneous technique. Open biopsy, which is an invasivesurgical procedure using a scalpel and involving direct vision of thetarget area, removes the entire mass (excisional biopsy) or a part ofthe mass (incisional biopsy). Percutaneous biopsy, on the other hand, isusually done with a needle-like instrument through a relatively smallincision, blindly or with the aid of an imaging device, and may beeither a fine needle aspiration (FNA) or a core biopsy. In FNA biopsy,individual cells or clusters of cells are obtained for cytologicexamination and may be prepared such as in a Papanicolaou smear. In corebiopsy, as the term suggests, a core or fragment of tissue is obtainedfor histologic examination which may be done via a frozen section orparaffin section. One important area where biopsies are performed is thediagnosis of breast tumors.

[0004] Traditionally, the biopsy technique for breast tumors involvesplacing a biopsy device multiple times into the breast and takingseveral samples of tissue from a mass or tumor which is suspected ofbeing cancerous. Several samples are required to be sure that sometissue from the suspect mass has been captured, and enough tissue hasbeen sampled to ensure that, if disperse cancer cells exist in thesuspect mass some of those cancer cells will be captured in the samples.Each time the device is placed the physician must locate and direct thedevice with ultrasound imaging into the correct position near thesuspect mass. Some breast tumors and lesions are very well defined, hardspherical masses which grow within the soft, compliant breast tissue. Itis difficult to force a needle into these lesions because they areresistant to puncture and fairly mobile. Forcing the biopsy needle intothe lesion is like trying to spear an apple floating in water.

[0005] Vacuum assisted biopsy system proposed by Biopsys involvessucking a breast lesion into a cannula and shearing off the capturededge of the lesion to obtain a biopsy sample. The device uses a vacuumto collect tissue into the side of an open tubular device, and then usesa rotating corer to cut the tissue collected. The rotating corer isslidable within the tubular section and can be pulled back to remove thetissue collected in the rotating corer. An additional stylet inside therotating corer can be used to push the tissue out of the core. Thedevice can be rotated on its axis to remove a sample, 360 degrees aroundthe central placement of the device. Typically, physicians sample six toeight cores. One advantage of this device is that the physician does nothave to remove the device for additional biopsy samples. However, thetumor itself must be re-engaged after every coring operation, whichentails substantial effort in relocation and confirmation that thetarget suspect mass has been engaged by the side aperture. Tumors may betoo tough to yield to the suction and deform as necessary to enter theside opening of the cannula. Doctors also currently use the device totake a circular sequence of cores by rotating the device about its longaxis or by sideways movement of the suction head to take a line ofcores.

[0006] After biopsy and analysis, the tumor must be treated with aseparate device, as Biopsys teaches that their coring device should notbe used for resection. Indeed, the device is not designed to performresection with assurance that complete resection of a suspect mass hasbeen accomplished. Mechanical cutting and disruption of the tissuestructure and cancer cell dispersion (that is, tearing of the tissuearound the cancer and movement of the cancer cells amongst normaltissue) will result in unintentional delivery of cancer cells intohealthy tissue adjacent the lesion.

SUMMARY

[0007] The devices and methods described below provide for diagnosis andtreatment of tumors within the breast. The devices include structureswhich permit the surgeon to secure a suspect mass or tumor within thebreast for an extended period of time and for several biopsies, coringprocedures, or resections. The suspect mass or tumor is secured to acannula for the entire diagnostic and treatment procedure, or subsets ofthe procedure such as biopsy or ablation. This allows the placement ofthe cannula with a single step utilizing methods such as ultrasound toguide the cannula toward the tumor.

[0008] The cannula includes a lumen adapted to be connected to a sourceof vacuum, which can be used to secure a breast lesion to the cannula. Aring seal on the proximal end of the catheter permits biopsy needles,cryoprobes or other ablation devices to be inserted through the cannulaand into the lesion while the vacuum on the cannula is maintained. Inthis manner, the needles and ablation devices may be inserted into thelesion while the lesion in held securely in place by the suction appliedto the cannula.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009]FIG. 1 illustrates the cannula adapted for use in securing abreast tumor during a biopsy or ablation procedure.

[0010]FIG. 2 illustrates the biopsy needle in use with the cannula ofFIG. 1.

[0011]FIG. 3 illustrates a multiple coring needle which may be used withthe cannula of FIG. 1.

[0012]FIG. 4 illustrates the placement of a cryoprobe or other ablativedevice within the cannula of FIG. 1.

[0013]FIG. 5 illustrates a method of breast tumor ablation for tumorslocated near the skin.

[0014]FIG. 6 illustrates a method of breast tumor ablation for tumorslocated near the skin.

[0015]FIG. 7 illustrates and adaptation of the cannula to provideadditional protection to the skin.

DETAILED DESCRIPTION OF THE INVENTIONS

[0016]FIG. 1 illustrates the biopsy and treatment device adapted for usein securing a breast tumor during the biopsy and treatment procedure.The patient 1 and the patient's breast 2 and skin 3 of the breast areshown schematically. The tumor, lesion or other suspect mass 4 islocated within the breast, surrounded by soft tissue and fatty tissue.The tumor in this illustration is a well defined, hard mass ranging insize from 3 to 40 mm in diameter, typical of a benign palpable tumor orfibro-adenoma, although the device and method may be used to treatfibrocystic disease and other conditions. The device comprises a cannula5 with a straight cut distal edge 6 adapted for insertion through asmall incision in the skin overlying the tumor and a proximal end 7which remains outside the breast. The proximal end of the cannula isfitted with hub 8 which serves as a handle and a manifold for theseveral connections to the cannula. This hub may be integral with thecannula or provided as a separate piece secured to the proximal end ofthe cannula. The cannula has a lumen 9 extending through the cannulafrom the distal edge to the proximal end of the cannula. On the hub, avacuum connection 10 in the form of Luer fitting provides a fluidconnection between the lumen of the cannula and a vacuum hose 11. Thevacuum hose may be connected to any source of vacuum or suction. On theproximal end of the hub, a valve 12 seals the cannula proximal endagainst air pressure but allows passage of the needles and probes usedin the procedure. The valve may be a self-sealing silicone plug 13provided with a slit 14 capable of accommodating the needles and probesby resiliently expanding and conforming around a needle or probe when aneedle or probe is forced through the slit, and resiliently closing toan airtight seal when the needles or probes are removed. Thus, the valveallows for insertion of various instruments and elongate medical deviceswhile maintaining the seal necessary to provide sufficient suction tohold the tumor. A stopper or cap 15 is provided for insertion into theslit when the valve is not occupied by a needle or probe to positivelyseal the valve. A backup valve, such as ball valve which opens to form aclear and straight lumen, may be placed in line before the valve 12 inplace of the stopper. The cannula is made of an acceptable biologicalmaterial such as Teflon™ (polytetrafluoroethylene (PTFE) or expandedpolytetrafluoroethylene (ePTFE)), carbon fiber, metal or metal compositefor maximum strength with minimal wall thickness. The self-sealing valveis comprised of silicone or other material of similar resilience andconformability. An additional valve 16 may be added on the proximalhandle, controlling a port 17 communicating between the vacuum lumen andthe exterior of the cannula. The valve illustrated is merely athumbslide mounted in a recess 18. This valve may be used to break thevacuum established in the vacuum lumen to release a lesion from thedistal tip of the device, or to bleed the vacuum from the lumen tolessen the suction on a lesion.

[0017]FIG. 2 illustrates the cannula in use with a biopsy needle 20 inplace within the lumen. A biopsy needle 20 fits within the lumen of thecannula and passes through the valve 12. The valve deforms and opensenough to allow the needle to pass through, yet still maintains asufficiently airtight seal to maintain the vacuum within the cannulalumen. The needle has a sharp distal tip 21 which can pierce the tumor4. The distal tip is shaped with a coring edge to collect tissue withinthe lumen 22 of the needle. As depicted in FIG. 2, suction has beenapplied to the cannula lumen through the vacuum hose 11 and connection10, thus drawing the tumor to the distal edge of the cannula andsecurely holding it in place. The biopsy needle has been insertedthrough the self-sealing valve and through the cannula lumen into andthrough the tumor. A small core of tumor tissue 23 has been forced intothe lumen of the needle. The needle may now be removed and the core oftumor tissue extracted and analyzed for the presence of cancer cells.When the needle is removed, the suction is maintained on the cannulalumen and the tumor remains securely engaged with the cannula distaledge. The biopsy needle (or another) can then be inserted through thecannula and into the tumor without having to relocate and reengage thetumor with the cannula. After all necessary biopsies have been taken,the sample tissue may be analyzed for the presence of cancer cells orother undesirable tissue for which ablation is indicated.

[0018]FIG. 3 illustrates a multiple coring needle 24 for use with thesystem. This needle includes several coring lumens 25 opening at thedistal end of the needle into coring edges 26. The coring lumens arespaced in a circle about the circumference of the needle, and extendfrom the distal tip 21 of the needle proximally to the proximal end ofthe needle. It may be used in place of the single biopsy coring needleas illustrated in FIG. 2. By providing suction to one or more of thelumens, the tumor is secured to the coring needle.

[0019]FIG. 4 illustrates the use of an ablative device, such ascryoprobe, with the cannula. The cryoprobe 27 fits within the lumen ofthe cannula and passes through the valve 12, and the distal tip of thecryoprobe is forced into the tumor until the active freezing portion ofthe probe resides within the tumor. During placement of the cryoprobe,the vacuum is maintained within the lumen so that the tumor is securelyengaged by the cannula. With the tumor secured by the vacuum, thecryoprobe may be easily forced into the tumor. The cryoprobe may beoperated to ablate the tumor with cryogenic freezing as required todestroy the tumor. To operate the cryoprobe, liquid or gas cryogenicfluids (such as liquid nitrogen, or gaseous argon in combination with aJoule-Thomson cryostat in the probe tip) are passed through the probe,supplied from a cryosurgical control system (not shown). The operationof the cryoprobe creates an iceball 28 which encompasses the lesion 4,and cools the lesion to lethal cryogenic temperatures. Any ablationdevice may be used in place of the cryoprobe, including RF ablationprobes, microwave ablation probes, laser ablation probes, or focusedultrasound energy probes. Temperature sensors 29 may be mounted on theskin over the lesion in order to monitor skin temperature, so that thesurgeon may avoid ablating the skin.

[0020] In use, the devices described above are used in place oftraditional biopsy, coring and ablation devices. Prior to use, thepatient is prepared and the breast is appropriately prepped and draped.The site is prepared using local anesthesia and, optionally, intravenoussedation. The patient is positioned on an operating table in the supineposition, with the patient on her back. (If the procedure isaccomplished under stereotactic guidance, the patient may be prone on astereotactic table, exposing the breast below the table.) The breast isimaged, if not previously imaged, to determine the location of lesions.A small incision is made in the breast to allow the cannula to be easilyinserted into the skin. The surgeon inserts the cannula into thepatient's breast through the incision, pushes it into the breast untilthe distal edge of the cannula is proximate to the boundary of thetumor. An ultrasound scanner, MRI, stereotactic, mammographic, infraredor other imaging device is used to obtain an image of the breast,including the tumor and any device inserted into the breast, and thesurgeon uses the display from the imaging device to assist in guidanceof the cannula to the tumor. With the cannula distal edge in positionnear the tumor, the surgeon applies vacuum to the cannula through theside port on the cannula. The vacuum draws the tumor toward the cannula,and the cannula securely engages the tumor until the suction is brokenat the end of the procedure. The surgical biopsy needle can be insertedthrough the cannula and into the tumor to retrieve a sample of tissuefor analysis. Because coring can be accomplished without removing theportion of the tumor engaged by the cannula, or otherwise disrupting thesuction between the cannula and the tumor, several biopsy samples may betaken without having to relocate and re-engage the tumor.

[0021] Depending on the analysis of the biopsy (whether or not thesamples obtained contain cancerous cells or other conditions), treatmentof the tumor may be required. If analysis can be accomplishedintra-operatively (that is, during a period of time in which it isfeasible to keep the patient in the operating room and maintain thetumor engaged with the cannula), and indicates the presence of cancerouscells or other condition for which ablation is indicated, an ablationinstrument can be inserted through the cannula and into the tumor. Ifso, the surgeon inserts an ablation instrument, such as a small calibercryoprobe, into the tumor. Preferably, the surgeon inserts a cryoprobethrough the valve and cannula and into the tumor, while maintainingsuction on the cannula. The surgeon initiates cooling of the cryoprobe,and cools the tumor through one or more cycles of cooling to cryogenictemperatures and subsequent warming and thawing. A double freeze-thawcycle is currently recommended. Each cycle consists of a 6 to 15 minutefreeze followed by thawing until the internal cryoprobe temperaturereaches 0° C. (approximately 6 to 15 minutes). The device may also beused without regard to biopsy results. Patients prefer to have theselesions treated, even if they prove to be benign. In current practice,should biopsy results indicate the presence of cancer, the patient mustreturn to the operating room shortly after the biopsy, undergopreparation, anesthesia, relocation of the lesion and ablation. Instead,the lesions may be ablated intraoperatively with the biopsy, immediatelyafter biopsy and without interrupting the procedure to await the biopsyresults. Should the biopsy prove negative for the presence of cancer,the patient will have received a substantially cosmetic treatment.Should the biopsy prove positive, the patient will have received anecessary therapeutic procedure. In addition to the ablative procedure,the positive biopsy may indicate the need for additional monitoring andtreatment.

[0022] For lesions deeper than 1 cm from the skin surface, the cryoprobeis advanced until the distal tip is located approximately in the centerof the lesion or just beyond the lesion. For smaller lesions (<2 cmdiameter) the ice ball may grow beyond the margins of the tumor, whilefor larger lesions, the ice ball may remain within the confines of thetumor. The cryoprobe tip temperatures and skin mounted thermocouplereadings are monitored throughout the ablation procedure. If thetemperature of the skin overlying the cryoprobe measures below freezing,freezing operation of the cryoprobes should be paused until it returnsto 10° C. (the temperature at the edge of the ice ball edge is 0° C. andexposure to such a temperature for the few minutes will not harm theskin, but caution should always be employed).

[0023] The procedure may be augmented with additional steps. Just priorto ablation treatment, prophylactic antibiotics can be administered atthe surgeon's discretion. Just prior to cryosurgical ablation, cryogenicenhancement agents may be injected directly into the tumor through ahypodermic needle inserted through the valve and cannula and into thetumor while it is secured by suction to the cannula. During coolingoperation of the cryoprobes, warm saline may be washed over the skinoverlying the tumor and iceball to prevent freezing of the skin.

[0024] If the lesion being treated is close to the skin such thatcryoablation of the lesion entails a danger of cryoablation of theoverlying skin, several milliliters of a resorbable material such assterile saline may be injected or inserted into the subcutaneous tissuebetween the skin and the lesion. This will create a thermally protectivemass or barrier layer between the tumor and the skin. Thermal protectionmay arise from insulative effect of the thermally protective mass ormerely by the distension or separation of the skin away from the tumorand thus away from the iceball. As illustrated in FIG. 5, where thetumor 4 is close to the skin 3, the thermally protective mass 30 isinjected between the skin 3 and the subcutaneous fat 31 of the breast.When the cryoprobe 27 is operated to create the iceball, the ice-ball 32either grows into the thermally protective mass or is inhibited ingrowth in the direction of the thermally protective mass (as illustratedby the non-spherical shape of the iceball in this illustration). Thismethod basically distends the skin away from the iceball. This may alsobe accomplished by dissecting the skin away from the tumor with aballoon inserted between the skin and fat in the area overlying thetumor. Balloon dissection can be accomplished as illustrated in FIG. 6.Here, a balloon 33 has been inserted subcutaneously between the tumor 4and the overlying skin 3. The balloon is inflated with air or othersterile gas, through inflation tube 34, creating a good layer ofinsulation between the cryoprobe and the overlying skin.

[0025]FIG. 7 illustrates and adaptation of the cannula to provideadditional protection to the skin. The cryoprobe 27 is inserted througha side lumen 35 provided on the cannula 5. The breast lesion 4 is drawnby vacuum to the tip of the cannula. The cryoprobe is advances distallyout of the side lumen until the freezing region underlies the lesion,and it operated to create the iceball 36. The iceball extendssuperficially toward the skin and to encompass the lesion, and alsoextends posteriorly into the breast, where some healthy breast tissue isablated but the overlying skin is not. This system and procedure alsohas the advantage that the lesion itself is not punctured, limiting thepotential for seeding due to the release of cancerous cells from thedisruption of the tissue of the tumor.

[0026] The cannula illustrated above is preferably 10 to 20 cm in lengthand about 3 mm in diameter with an internal diameter of 2.8 mm, and aclearance of about 0.25 mm between the inner bore of the cannula and anydevice inserted through the cannula during suction. The cryoprobes maybe Joule-Thomson probes, liquid cryogen probes, or probes of otherdesigns. Various other ablative devices may be used in place of thecryoprobe, including laser ablation devices, RF ablation devices,chemical ablation catheters and any other ablative technology proposedfor use to destroy tumors and lesions. The vacuum applied is preferablyin the range of 14 to 21 inches of mercury vacuum.

[0027] The devices and methods illustrated above have been illustratedin relation to the treatment of tumors and lesions within the breast.However, they may be used to treat tumors and lesions throughout thebody wherever the tumors which are difficult to secure and locate areencountered, and wherever nearby tissue must be protected from freezing.Thus the devices and methods may be used for tumors and lesions of theuterine tube (such as uterine fibroids), kidney, liver, prostate orbrain.

[0028] Thus, while the preferred embodiments of the devices and methodshave been described in reference to the environment in which they weredeveloped, they are merely illustrative of the principles of theinventions. Other embodiments and configurations may be devised withoutdeparting from the spirit of the inventions and the scope of theappended claims.

We claim:
 1. A device for treating or sampling a mass of tissue within a human patient, said device comprising: a cannula having a distal end adapted for insertion into the body of the patient, a proximal end, and a lumen extending through the cannula and defining a proximal opening and a distal opening in the cannula, said distal end of the cannula having substantially intact sidewalls; a fitting disposed on the proximal end of the cannula, said fitting adapted for connection to a vacuum source; an airtight seal in the proximal opening of the cannula, said airtight seal permitting passage of elongate medical devices through the seal while substantially maintaining the airtight seal; at least one elongate medical device sized and dimensioned to pass into the lumen through the airtight seal and extend beyond the distal end of the cannula, said elongate medical device having a distal tip adapted for penetration into tissue secured to the distal end of the cannula.
 2. A system for treating or sampling a mass of tissue within a human patient, said device comprising: a cannula having a distal end adapted for insertion into the body of the patient, a proximal end, and a lumen extending through the cannula and defining a proximal opening and a distal opening in the cannula, said distal end of the cannula having substantially intact sidewalls; a fitting disposed on the proximal end of the cannula, said fitting adapted for connection to a vacuum source; an airtight seal in the proximal opening of the cannula, said airtight seal permitting passage of elongate medical devices through the seal while substantially maintaining the airtight seal; a source of vacuum pressure operably connected to the fitting; an elongate medical device capable of insertion through the airtight seal and into the cannula, said elongate medical device being long enough to extend from the proximal end of the cannula to a distance outside the distal opening of the cannula.
 3. The system of claim 1 or 2 wherein the elongate medical device is a biopsy needle.
 4. The system of claim 1 or 2 wherein the elongate medical device is a cryoprobe.
 5. The system of claim 1 or 2 wherein the elongate medical device is an ablation device suitable for ablation of the mass.
 6. A method of performing cryosurgery of a lesion in the body of a patient, said method comprising; providing a cannula having a distal end adapted for insertion into the body of the patient, a proximal end, and a lumen extending through the cannula and defining a proximal opening and a distal opening in the cannula, said distal end of the cannula having substantially intact sidewalls; inserting the cannula into the body of the patient so that the distal edge of the cannula is proximate the lesion; applying suction to a lumen of the cannula, thereby drawing the lesion toward the cannula; inserting an ablative medical device through the lumen of the cannula and into the lesion; operating the ablative medical device to ablate the lesion.
 7. A method of performing cryosurgery of a lesion in the body of a patient, said method comprising; providing a cannula having a distal end adapted for insertion into the body of the patient, a proximal end, and a lumen extending through the cannula and defining a proximal opening and a distal opening in the cannula, said distal end of the cannula having substantially intact sidewalls; inserting the cannula into the body of the patient so that the distal edge of the cannula is proximate the lesion; applying suction to a lumen of the cannula, thereby drawing the lesion toward the cannula; inserting a cryoprobe through the lumen of the cannula and into the vicinity of the lesion; operating the cryoprobe to ablate the lesion.
 8. A method of performing cryosurgery of a lesion in the breast of a patient, the lesion being located under a portion of overlying skin, said method comprising; providing a cannula having a distal end adapted for insertion into the body of the patient, a proximal end, and a lumen extending through the cannula and defining a proximal opening and a distal opening in the cannula, said distal end of the cannula having substantially intact sidewalls; inserting the cannula into the body of the patient so that the distal tip of the cannula is proximate the lesion; applying suction to a lumen of the cannula, thereby drawing the lesion toward the distal tip cannula; inserting a cryoprobe into the breast and into the vicinity of the lesion; operating the cryoprobe to ablate the lesion.
 9. The method of claim 8 further comprising: inserting the cryoprobe into the lesion by inserting it through the lumen of the cannula and then advancing the cryoprobe distally from the lumen of the cannula and into the lesion.
 10. The method of claim 8 further comprising: inserting the cryoprobe into the lesion.
 11. The method of claim 8 further comprising: inserting the cryoprobe into the breast in a position posterior to the lesion.
 12. The method of claim 8 further comprising: placing a thermally protective mass between the lesion and the overlying skin prior to operating the cryoprobe to ablate the lesion. 